Status:
COMPLETED
An Observational Study of Multiple Sclerosis (MS) Patients Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment With Mitoxantrone
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
Brief Summary
This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study to investigate whether baseline treatment with high-dose interferon beta 1a (Rebif 44 μg x 3 ), administered ...
Detailed Description
The treatment of relapsing-remitting MS with interferon-beta has established itself as first-choice treatment. In previous clinical studies, the interferon-beta 1a (Rebif) used within the scope of thi...
Eligibility Criteria
Inclusion
- Subjects with a clinically demonstrated diagnosis of MS and present relapses
- Subjects who were relapse-free for the past 6 months with an Expanded Disability Status Scale (EDSS) range between 2 and 6
- Subjects who had a stable disease status during the past few months
- The last administration of mitoxantrone had been more than 3 months previously. In addition, the mitoxantrone treatment was given for at least a 12-month period, but for not more than 24 months, within a total dosage of 60-120 mg/m2 body surface area
Exclusion
- Subjects with MS with secondary progression (SPMS) without relapse activity, pregnant or breast-feeding patients, as well as subjects with contraindications
- Subjects with existing systemic concomitant diseases (e.g. diabetes, heart, liver or kidney diseases)
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01142518
Start Date
July 1 2005
End Date
March 1 2009
Last Update
March 18 2014
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